Insulin-dependent Gestational DiabetesPhase 2NCT01018602
PINGUIN (Postpartum Intervention in Women With Gestational Diabetes Using Insulin)
A Phase 2 study testing vildagliptin and inactive pill in people with Insulin-dependent Gestational Diabetes, run by Institut fur Diabetesforschung, Munich, Germany at 1 site in Germany.
Trial summary
The aim of the study is to prove the efficacy of the oral intake of vildagliptin in a daily dose of 100 mg in scope of the development of type 2 diabetes in women with insulin dependent gestational diabetes in their last pregnancy not longer than 9 months after birth. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Insulin-dependent Gestational Diabetes
- What is being tested?
- vildagliptin and inactive pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2008to Jun 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- women with insulin-dependent gestational diabetes during the last pregnancy
- < 9 months after delivery
- age 18 years or older
- contraception during intervention period (at least 24 months)
Who cannot join
- pregnancy or lactation
- GADA or IA-2A positivity
- clinical overt diabetes
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Institut fuer Diabetesforschung
Munich, 80804
Anette G Ziegler, MD, +49 (0)89 3068 2917 ext. 2917, anziegler@lrz.uni-muenchen.de
Anette G Ziegler, MD
About this study
Official title: A Phase II, Randomized, Double-blind, 2-arm Controlled Study to Evaluate Efficacy of the DPPIV-inhibitor Vildagliptin for Prevention of Type 2 Diabetes in Women With a Recent History of Insulin-requiring Gestational Diabetes
The aim of the study is to prove the efficacy of the oral intake of vildagliptin in a daily dose of 100 mg in scope of the development of type 2 diabetes in women with insulin dependent gestational diabetes in their last pregnancy not longer than 9 months after birth.
In this randomized, placebo-controlled, double-blinded clinical phase II study, 140 participants aged 18 years or older and an insulin dependent gestational diabetes in their last pregnancy should be included and treated with vildagliptin or placebo over 24 months, followed by a 12 months observation period. Exclusion criteria are pregnancy and lactation as well as a clinical overt diabetes or islet autoimmunity.
Read more
The null hypothesis is that there is no significant difference of diabetes incidence (according to ADA criteria 1997) in both groups.
Primary endpoint is the clinical manifestation of diabetes, secondary endpoints include the improvement of beta cell function (evaluable by C-peptide measurement) and of insulin sensitivity by the treatment with vildagliptin.
- Conditions
- Insulin-dependent Gestational Diabetes
- Being tested
- vildagliptin, inactive pill
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vildagliptinDrug
100 mg per day over 24 months
inactive pillDrug
1 pill per day over 24 months
| Study group | Role | What they receive |
|---|---|---|
| vildagliptin | Active comparator | Not described Receives: Drug: vildagliptin |
| inactive pill without active agent | Placebo comparator | participants receive an inactive pill without active agent, but undergo the same examinations, visits and tests as the group treated with vildagliptin. Receives: Drug: inactive pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
development of type 2 diabetes mellitus by criteria of ADA 1997
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2009 (estimated)
- Study startJan 2008
- Primary completionJun 2012 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Insulin-dependent Gestational DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut fur Diabetesforschung, Munich, Germany
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01018602
- Sponsor's protocol ID
- 808040006
- Status last verified
- Jun 2011
- First submitted
- 20 Nov 2009
- Last updated
- 27 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hummel S, Beyerlein A, Pfirrmann M, Hofelich A, Much D, Hivner S, Bunk M, Herbst M, Peplow C, Walter M, Kohn D, Hummel N, Kratzsch J, Hummel M, Fuchtenbusch M, Hasford J, Ziegler AG; PINGUIN Study Group. Efficacy of vildagliptin for prevention of postpartum diabetes in women with a recent history of insulin-requiring gestational diabetes: A phase II, randomized, double-blind, placebo-controlled study. Mol Metab. 2018 Mar;9:168-175. doi: 10.1016/j.molmet.2017.12.015. Epub 2018 Jan 3.
PubMed 29396374
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Double-blind, 2-arm Controlled Study to Evaluate Efficacy of the DPPIV-inhibitor Vildagliptin for Prevention of Type 2 Diabetes in Women With a Recent History of Insulin-requiring Gestational Diabetes
- ClinicalTrials.gov ID
- NCT01018602
- Acronym / sponsor ID
- 808040006
- Conditions
- Insulin-dependent Gestational Diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Institut fur Diabetesforschung, Munich, GermanyUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 23 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to prove the efficacy of the oral intake of vildagliptin in a daily dose of 100 mg in scope of the development of type 2 diabetes in women with insulin dependent gestational diabetes in their last pregnancy not longer than 9 months after birth.
In this randomized, placebo-controlled, double-blinded clinical phase II study, 140 participants aged 18 years or older and an insulin dependent gestational diabetes in their last pregnancy should be included and treated with vildagliptin or placebo over 24 months, followed by a 12 months observation period. Exclusion criteria are pregnancy and lactation as well as a clinical overt diabetes or islet autoimmunity.
The null hypothesis is that there is no significant difference of diabetes incidence (according to ADA criteria 1997) in both groups.
Primary endpoint is the clinical manifestation of diabetes, secondary endpoints include the improvement of beta cell function (evaluable by C-peptide measurement) and of insulin sensitivity by the treatment with vildagliptin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vildagliptin | Active comparator | Drug: vildagliptin |
| inactive pill without active agent | Placebo comparator | Drug: inactive pillparticipants receive an inactive pill without active agent, but undergo the same examinations, visits and tests as the group treated with vildagliptin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- women with insulin-dependent gestational diabetes during the last pregnancy
- < 9 months after delivery
- age 18 years or older
- contraception during intervention period (at least 24 months)
Key exclusion criteria (3 listed)
- pregnancy or lactation
- GADA or IA-2A positivity
- clinical overt diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vildagliptin100 mg per day over 24 months | Drug | vildagliptin |
| inactive pill1 pill per day over 24 months | Drug | inactive pill without active agent |
Primary outcome
development of type 2 diabetes mellitus by criteria of ADA 1997
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2011.
- Derived from this study: PubMed 29396374Hummel S, Beyerlein A, Pfirrmann M, Hofelich A, Much D, Hivner S, Bunk M, Herbst M, Peplow C, Walter M, Kohn D, Hummel N, Kratzsch J, Hummel M, Fuchtenbusch M, Hasford J, Ziegler AG; PINGUIN Study Group. Efficacy of vildagliptin for prevention of postpartum diabetes in women with a recent history of insulin-requiring gestational diabetes: A phase II, randomized, double-blind, placebo-controlled study. Mol Metab. 2018 Mar;9:168-175. doi: 10.1016/j.molmet.2017.12.015. Epub 2018 Jan 3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing vildagliptin and inactive pill in people with Insulin-dependent Gestational Diabetes, run by Institut fur Diabetesforschung, Munich, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anette G Ziegler, MD (+49 (0)89 3068 2917 ext. 2917, anziegler@lrz.uni-muenchen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
development of type 2 diabetes mellitus by criteria of ADA 1997 (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01018602, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2011.